MAUDE Adverse Event Report: AV-TEMECULA-CT RX ACCULINK CAROTID STENT SYSTEM

Catalog Number 1011340-40

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the left carotid.The 8x40mm rx acculink self expanding stent system (sess) was advanced through the 6fr sheath with no resistance, when it was noticed under fluoro that the shaft had separated.The proximal portion of the sess was simply withdrawn from the sheath.A snare device was used to retrieve the separated portion of the shaft.Another device was used to complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspections were performed on the returned device.The reported separation was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7634270
• MDR Text Key: 112192471
• Report Number: 2024168-2018-04932
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 1011340-40
• Device Lot Number: 7021361
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COOK SHUTTLE SHEATH 6FNAV6 EMBOLIC PROTECTION
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR